Gastrointestinal CancerNCT04077372
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
A study testing Serious Illness Conversation Guide (SICG) and Quality of Life (QOL) survey in people with Gastrointestinal Cancer and Colorectal Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- Serious Illness Conversation Guide (SICG) and Quality of Life (QOL) survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 11 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with metastatic colorectal cancer whose tumor has progressed on both FOLFOX and FOLFIRI.
- Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy.
- Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies mentioned above.
- Patients with metastatic pancreatic adenocarcinoma.
- Patients with metastatic gastric or esophageal cancer whose tumor has progressed through first-line chemotherapy of any type.
- Patients with metastatic cholangiocarcinoma whose tumor has progressed through first-line chemotherapy of any type.
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- Patients with metastatic hepatocellular carcinoma whose tumor has progressed through PD1 blockade.
- Patients with metastatic high-grade neuroendocrine tumor.
- A patient with a metastatic GIST that has progressed through first-line tyrosine kinase inhibitor.
- Expected life expectancy of at least one month
Who cannot join
- Any patient not meeting the above criteria
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.
Read the detailed description
Primary Objective: To determine whether the Serious Illness Conversation Guide will improve the consistency with which providers have and document conversations regarding patients' goals and priorities as they near the end of life.
Secondary Objectives: 1. To assess whether having conversations as per this model will improve the quality of care near the end of life as determined by appropriate care in concordance with their goals of care.
- To assess whether having conversations as per this model will improve patient Quality of Life (QOL) as per a validated scale.
- To assess in patients with concordant care whether this model will improve patient QOL as per a validated scale 4. To assess provider opinions about end-of-life conversations.
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma
- Being tested
- Serious Illness Conversation Guide (SICG), Quality of Life (QOL) survey
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Cholangiocarcinoma, Carcinoma, Hepatocellular, Neuroendocrine Tumors, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious Illness Conversation Guide (SICG)Behavioural
The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients.
Quality of Life (QOL) surveyBehavioural
Quality of life survey by questionnaire (FACT-G) given every three months
| Study group | Role | What they receive |
|---|---|---|
| Serious illness conversation guide (SICG) | Experimental | Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter. Receives: Behavioral: Serious Illness Conversation Guide (SICG); Behavioral: Quality of Life (QOL) survey |
| Conversations by treating team | Active comparator | Patients have conversations as determined by treating team (but not using SICG tool). Receives: Behavioral: Quality of Life (QOL) survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportions of patients with documented goals of care
Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms
Measured: 1 year
Secondary outcomes (3)
Difference in proportions of patients with appropriate care toward end of life
Proportion of patients receiving appropriate care in line with their goals of care toward the end of life, by arm will be assessed.
Measured: 1 year
Comparison of QOL survey measures by section
Comparison of survey QOL measures by section for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score
Measured: 1 year
Overall comparison of QOL survey
Comparison of survey QOL measures overall for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start16 Sep 2019
- Primary completion11 Oct 2020
- Study completion11 Oct 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler P Johnson, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077372
- Sponsor's protocol ID
- IRB-51256
- Other IDs
- VAR0179, IRB-51256, NCI-2019-07235
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
- ClinicalTrials.gov ID
- NCT04077372
- Acronym / sponsor ID
- IRB-51256
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 11 Oct 2020 (actual)
- Study completion
- 11 Oct 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.
Detailed description
Primary Objective: To determine whether the Serious Illness Conversation Guide will improve the consistency with which providers have and document conversations regarding patients' goals and priorities as they near the end of life.
Secondary Objectives: 1. To assess whether having conversations as per this model will improve the quality of care near the end of life as determined by appropriate care in concordance with their goals of care.
- To assess whether having conversations as per this model will improve patient Quality of Life (QOL) as per a validated scale.
- To assess in patients with concordant care whether this model will improve patient QOL as per a validated scale 4. To assess provider opinions about end-of-life conversations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious illness conversation guide (SICG) | Experimental | Behavioral: Serious Illness Conversation Guide (SICG), Behavioral: Quality of Life (QOL) surveyPatients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter. |
| Conversations by treating team | Active comparator | Behavioral: Quality of Life (QOL) surveyPatients have conversations as determined by treating team (but not using SICG tool). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with metastatic colorectal cancer whose tumor has progressed on both FOLFOX and FOLFIRI.
- Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy.
- Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies mentioned above.
- Patients with metastatic pancreatic adenocarcinoma.
- Patients with metastatic gastric or esophageal cancer whose tumor has progressed through first-line chemotherapy of any type.
Key exclusion criteria (2 listed)
- Any patient not meeting the above criteria
- Non-English speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious Illness Conversation Guide (SICG)The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients. | Behavioural | Serious illness conversation guide (SICG) |
| Quality of Life (QOL) surveyQuality of life survey by questionnaire (FACT-G) given every three months | Behavioural | Conversations by treating team, Serious illness conversation guide (SICG) |
Primary outcome
Difference in proportions of patients with documented goals of care
Time frame: 1 year
Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms
3 secondary outcomes
Difference in proportions of patients with appropriate care toward end of life
Time frame: 1 year
Comparison of QOL survey measures by section
Time frame: 1 year
Overall comparison of QOL survey
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler P Johnson, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Illness Conversation Guide (SICG) and Quality of Life (QOL) survey in people with Gastrointestinal Cancer and Colorectal Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportions of patients with documented goals of care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.